JP2008520377A - Spine plug of minimally invasive facet joint fusion system - Google Patents

Abstract

  The frustum-shaped main body has a hole on the upper surface and a pair of first and second opposing holes on the side surface, and the first and second horizontal grooves inside the first opposing hole and the second Connect both opposing holes. A vertical groove from the upper surface hole is connected to the first groove and the second groove. After the body is inserted into the face joint hole, a compatible synthetic or biological material is inserted into the vertical groove until the material exits from the first and second holes in the side. At least one pair of flanges on a portion of the exterior side of the body serves as a detent to hold the body in place within the face joint hole.

Description

  The present invention generally relates to minimally invasive spinal surgery, and more particularly, either prefabricated, pre-formed synthetic cortical bone, or a harvested and compacted iliac prosthesis graft, autograft or cadaveric allograft. In order to insert the device, it relates to using an instrument configuration of a facet joint surgery with an arthroscopic entrance or by incision. This graft and fusion system is limited to 48 facet joints located in the spine, C1-C2 to L5-S1.

  In the United States alone, about 10% of the total population will suffer from back pain in the next 12 months. Over the next year, with the exception of common colds and flu, more people will suffer from back pain than any other injury or illness. About one third of them will not recover, and will have to live with symptoms that hinder sustained life. This number is cumulative every year.

  One type of root cause of back pain, particularly persistent life, is a facet joint, a small joint that allows movement of the spine located behind the adjacent vertebrae of the spine.

  The current surgical solution available to millions of people with facet dysfunction is a high-risk operation based on a complex and invasive pedicle screw with a long recovery time of 6 to 24 months With uncertain results. Due to the high risk, litigation is frequent, which forces non-surgical symptomatic treatment and at the same time worsens the consequences of the disease or injury. Some such efforts provide intervertebral fusion as described in US Pat. No. 6,485,518 and US Patent Application 2003/0032960. Numerous patents have been granted to date for general fusion of the spine, which may or may not include facet joints by approximation or design.

  With the emergence of new, safer and less invasive surgical techniques and techniques, advances in spinal surgery now outperform all other orthopedic fields. The progress is further amplified by the huge demand.

The use of preformed harvested bone or synthetic bone as a structural immobilization in face articulation has three distinct advantages over pedicle screws or compression screws currently used in face articulation procedures. Have sex. (1) The use of bone rather than metal allows for natural ingrowth of bone and a more firm and permanent fusion, and (2) natural or synthetic implants are screw-type fixed There is no possibility of loosening over time, which is a concern in the Chemical Law.
US Pat. No. 6,485,518 US Patent Application 2003/0032960

  This implant and system is specifically designed for use with minimally invasive or arthroscopic entry points for stand-alone procedures and is used as an accessory in instrumented vertebral fusion When done, it provides a more robust and unique superior healing technique by greatly reducing the risk of face joint pain resulting from sustained face joint movement.

  Minimally invasive facet joints used in the treatment of affected or painful facet joints not suitable for surface reconstruction or replacement are arthroscopic spinal surgery or conventional Instrument configuration and autograft, cadaver allograft, or Food and Drug Administration approved reserve for use in open surgery, and more specifically for fusion of C1-C2 to L5-S1 spinal joints Making and using pre-formed synthetic cortical bone grafts. This system serves as a primary or corrective operation.

  The present invention provides an alternative to transplantation to facilitate fusion using an arthroscopic entry or incision surgical technique for C1-C2 to L5-S1 vertebral joints. Achieve superior joint healing.

  According to one broad aspect of the present invention, the arthroscopic lower surface joint fusion system comprises a punch or drill that drills in a conical shape through both sides of the facet joint. This hole is formed by the patient's own harvested bone plug, or iliac protuberance autograft, prefabricated, pre-formed cortical cadaver allograft (autograft or allograft is formed by pressing or processing the bone plug ) Or pre-fabricated by the Food and Drug Administration, densely formed bone plugs using pre-formed synthetic implants.

  This punch or drill uses an arthroscopic entry or similar entry to access the joint, or drills through both sides of the intervertebral facet joint in conventional open surgery Including any number of possible components. By way of example only, this punch / drill uses a mechanical component resized to work from an arthroscopic opening, similar to a typical plier, to drill a hole of a specific size. A manual actuator that creates enough pressure to open across both sides of the. In addition, a drill guide can be placed and a drill head of a specific size and shape can be used to create an opening in the facet joint either horizontally or vertically.

  Bone plug press (graft forming or compression device) is used to correlate punched or drilled bone tunnels, cortical bone from harvested autografts, cortical bone from cadaver allografts, or It includes any number of components that can use synthetic substitutes. By way of example only, bone plug presses include mechanisms similar to common pliers, or more standard manual presses, which form bone plugs by squeezing the handles together. Sufficient force to form a bone plug and compress the bone or synthetic substitute to the appropriate density and shape.

  The impactor or tamp includes any number of components that can push the bone plug into the bone tunnel and compress it. Sutures or metal overlays can be added to provide additional structural stability to the joint during graft coalescence.

  Many advantages of the present invention will become apparent to those skilled in the art when the specification is read in conjunction with the accompanying drawings. Like reference numerals refer to like elements in the accompanying drawings.

  Referring to FIG. 1, the bone plug of the present invention is an inverted frustum-shaped device 10 for inserting a synthetic or biological material that helps to fuse the bone plug 10 into place in the spinal joint 15. It has a vertical center groove 12. The bone plug 10 has a number of sides 14 and 16 for discharging synthetic or biological material from the central groove 12. A coplanar pair of opposing flanges 18 and 20 partially bypass bone plug 10 in the vicinity of bottom end 22 having a smaller diameter than top end 24.

  To fuse the spinal facet joint, a tapered drill 26 shown in FIG. 2 is used to create a hole 28 between the two bones 30 and 32 shown in FIG. As can be seen in FIG. 4, an infusion tube 34 is inserted into the groove 12 so that a synthetic or biological material 36 can be inserted into the bone plug 10. As shown in FIG. 5, biological material 36 flows down groove 12 and excess biological material flows from sides 14 and 16 through grooves 42 and 44, respectively, to provide bone 30 and 32 and the outer sidewall of bone plug 10. 40 into the space 38 between. Flanges 18 and 20 serve as detents that hold bone plug 10 in place within hole 28. As can be further seen in FIG. 7, the biological material 36 flows outwardly from the openings 14 and 16 and into the space 38 to cement the plug 10 in place.

  An alternative plug 10a is shown in FIGS. Central groove 12a delivers biological material to side grooves 46, 42, and 44a. Similarly, the biological material 36 flows out of the openings 52, 14a, and 16a and promotes bonding to the bone. A second pair of parallel flanges 48 and 50 are added to the flanges 18a and 20a to increase the strength of the plug 10a in the hole 28. Similarly to the plug 10, the diameter of the side wall 40a is smaller at the bottom end 22a than at the upper end 24a.

If the joint is determined to be too damaged or affected to perform current replacement methods or candidate methods such as facet joint arthroplasty, minimally invasive facet arthroplasty involves three main It is expected to be an excellent alternative for some reason.
(1) In contrast to major surgery performed in hospitals, minimally invasive surgery can be performed in an outpatient setting. This treatment method can also be performed by open surgery when it is necessary to unite the facet joint in conjunction with vertebral fusion using instruments, as determined by the physician.
(2) The recovery time is estimated to be several weeks as opposed to 6 to 12 months.
(3) The progress of biological materials and synthetic substitutes can be fully utilized.

The present invention addresses overcoming, or at least improving, the disadvantages of the prior art by accomplishing the following:
• Reversing the cost / benefit ratio of current treatments for the present invention.
• Minimally invasive treatment for large open surgery • Outpatient surgery for hospitalization (approximately 20 minutes for several hours per joint). Note: This procedure can also be performed in open surgery at the discretion of the surgeon.
• Can be used to augment current incision healing techniques to reduce the need for bone stimulation, especially in high-risk groups such as smokers and multi-level cases.
・ Decrease in complication rate.
・ Reduce blood loss.
・ Reduction of anesthesia time.
・ Risk reduction.
• Dramatic reduction in recovery time.
• Minimal scarring that reduces the risk of dysfunctional back syndrome and improves the outcome of corrective surgery.
• Reduce the risk of post-operative infection by significantly reducing operating room time and soft tissue destruction.
• Do not rule out other surgical or non-invasive treatment options.
Existing cortical bone harvesting procedures using new techniques and in combination with a unique instrument configuration for shaping and producing bone, or pre-forms that are generally available with the approval of the Food and Drug Administration, Taking advantage of any of the pre-fabricated new synthetic cortical bone substitutes, we expect a high success rate by utilizing generally accepted arthroscopic procedures.

  The availability of this system and graft replacement is expected to dramatically increase the number of operations performed, which is the first safe outpatient procedure for major causes of spinal pain. This is because it provides a solution. Virtually all patients undergoing this treatment can walk on the same day and are expected to be fully functional in a few weeks. Current surgical solutions require approximately 3 days of hospitalization and a recovery period of 6 to 24 months.

  Apart from the clearly favorable clinical outcomes, there is a significant beneficial financial impact on insurers for sickness, employee compensation and health care.

  The spinal facet implant unit is calculated for each joint. Each patient has two joints for one spinal segment, 24 segments for a total of 48 face joints, ie C1-C2 to L5-S1. In many cases, one operation includes a plurality of joints.

  The present invention addresses overcoming, or at least improving, the disadvantages of the prior art.

  When inserting the plug 10, a tapered drill is used in particular from an arthroscopic entrance that allows access to the joint from a small incision and progressive expansion of the interfering soft tissue. This instrument design does not preclude use in conventional open surgery or other forms of limited incision access to the facet joint. The opening 28 is slightly smaller than the bone plug 10 to create proper fixation of the plug 10 and joint.

  Referring again to FIGS. 1 and 8, a fused face joint plug with one molded autograft, cadaver allograft, or pre-fabricated, pre-formed synthetic cortical bone plug, approved by the Food and Drug Administration. 10, 10a, or 10b is shown. The diameter of the front end 22 or 22a of the plug 10 or 10a is 3 mm to 8 mm, the diameter of the rear end 24 or 24a of the plug 10, 10a or 10b is 4 mm to 12 mm, and a wide part is located at the rear part. It becomes a frustum shape that makes it easy to fix by coalescence of bone grafts. This procedure is envisioned to require only one bone plug for one face joint and two bone plugs for one level. Permanent immobilization occurs when, over time, bone ingrowth occurs in the joint itself and into the plug.

  When no additional biological material is required, a frustum shaped bone graft 10b can be used, as shown in FIG.

  Other equivalent elements may be substituted for the elements disclosed herein to produce substantially the same results in substantially the same way.

It is a figure which shows the frustum-shaped bone plug of this invention used by a facet joint fusion technique. FIG. 5 shows a tapered drill used to make a bone plug. FIG. 5 shows a hole made for a bone plug. FIG. 4 shows a bone plug inserted into the hole of FIG. 3 with an infusion tube for inserting synthetic or biological material. FIG. 5 is a cross-sectional view taken along line 5-5 in FIG. 4. FIG. 6 is a cross-sectional view taken along line 6-6 in FIG. FIG. 7 is a cross-sectional view according to FIG. 6 showing a synthetic or biological material that cements the bone plug in place. FIG. 5 shows a first alternative bone plug with a frustum shape. FIG. 9 is a cross-sectional view of the frustum-shaped bone plug of FIG. 8 taken along lines 9-9. FIG. 10 shows a second alternative bone plug with a frustum shape.

Claims (21)

A face joint fusion plug,
A substantially solid frustum-shaped body having one hole on an upper surface, a pair of opposing first holes on a side surface, and a pair of opposing second holes on the side surface, A body positioned in a lower portion of the body distal from the top surface, and a second hole facing one of the holes;
A vertical groove directed downward from the hole on the upper surface, intersecting a first horizontal groove connecting the first pair of opposed holes, and the second pair of opposed holes A groove terminating in a second horizontal groove connecting the two;
At least one pair of flanges partially surrounding the bottom portion of the outer surface of the body;
A facet joint fusion plug comprising: synthetic cortical bone; and a body formed from a material selected from the group consisting of a harvested synthetic cortex and a densely molded iliac protuberance graft and cadaver allograft.   The facet joint fusion according to claim 1, wherein there is a third pair of opposing holes on the side of the body, and the vertical groove intersects a third horizontal groove connecting the third pair of holes. plug.   The facet articulation plug of claim 1, wherein a second pair of flanges partially surrounds a bottom portion of the exterior surface of the body.   The facet joint fusion plug of claim 2, wherein a second pair of flanges partially surrounds a bottom portion of the exterior surface of the body.   The face joint fusion plug according to claim 1, wherein the first horizontal groove and the second horizontal groove are on parallel horizontal planes.   The face joint fusion plug according to claim 2, wherein the third horizontal groove is on a parallel horizontal plane above the first horizontal groove and the second horizontal groove.   The face joint fusion plug of claim 1, wherein the body is formed from synthetic cortical bone.   The facet joint fusion plug of claim 1, wherein the body is formed from a harvested and densely molded iliac protuberance implant.   The facet joint fusion plug of claim 1, wherein the body is formed from a cadaver allograft. A plug attached to a hole between bones forming a face joint,
A substantially solid frustum-shaped body having one hole on the top surface, the top surface having a larger diameter than the bottom surface;
A first pair of opposing holes on the side of the body, the holes being connected by a first horizontal groove;
A second pair of opposed holes on the side of the body, the holes being connected by a second horizontal groove in a plane parallel to the first horizontal groove;
A vertical groove directed downward from the hole in the top surface, intersecting the first horizontal groove and terminating in the second horizontal groove;
At least one pair of flanges partially surrounding a bottom portion of the outer surface of the body;
A plug comprising bone-compatible synthetic or biological material that passes through the hole in the upper surface and exits the first pair of holes and the second pair of holes in the side of the body.   The third pair of opposing holes are connected by a third horizontal groove that intersects the vertical groove, and the synthetic or biological material exits from the third pair of holes. A plug attached to a hole between bones that form a face joint.   11. The plug attached to the hole between the bones forming the facet joint of claim 10, wherein there are two spaced apart flanges that partially surround the bottom portion of the outer surface of the body.   11. The facet joint according to claim 10, wherein the body is formed from a material selected from the group consisting of synthetic cortical bone and a minced and compacted iliac protuberance graft and cadaver allograft. A plug attached to the hole between the bones to be formed.   14. A plug body according to claim 13, formed from synthetic cortical bone.   14. A plug body according to claim 13 formed from a harvested and compacted iliac protuberance graft.   14. The plug body of claim 13 formed from an iliac cadaver allograft. A method of attaching plugs to face joints C1-C2 and L5-S1,
Incising an arthroscopic entry hole in the tissue of a patient outside the affected or damaged face joint; and
Drilling a hole between two opposing bones forming the face joint;
Inserting a pre-frustrated plug into the hole, the plug having substantially the same shape as the hole;
Providing the plug with a hole in the top surface, wherein the diameter of the top surface is greater than the diameter of the bottom surface;
Providing the plug with at least one pair of flanges partially surrounding an outer sidewall and at least a first and second pair of opposing side holes in the sidewall of the plug;
Providing an internal cortical groove from the hole in the upper surface to a first horizontal groove connecting the first pair of holes and a second horizontal groove connecting the second pair of holes;
Inserting an injection tube into the hole in the upper surface;
Inserting a synthetic or biological material compatible with bone into the infusion tube;
Applying sufficient pressure to the synthetic or biological material to cause discharge of the material from the sidewall hole.   The method of claim 17, wherein the preformed plug is provided as synthetic cortical bone.   The method of claim 17, wherein the preformed plug is provided as a densely molded iliac protuberance graft.   The method of claim 17, wherein the preformed plug is provided as a cadaver allograft.   A solid plug attached to a hole between bones forming a face joint, comprising a rear end portion having a diameter of 4 mm to 12 mm and a front end portion having a diameter smaller than the rear end portion. A plug comprising a substantially frustum-shaped body.

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